By Donald Zuhn --
Earlier this month, the U.S. Food and Drug Administration announced that the agency has approved 35 new drugs over the past twelve months. With the exception of 2009, when 37 new drugs were approved, more drugs were approved in fiscal year (FY) 2011, which ended September 30, than in any other year over the past decade. The largest number of drug approvals occurred in 1996, when the FDA approved 53 new drugs; the number of annual approvals declining since then.
The new drugs approved this year include two new drugs for hepatitis C and drugs for late-stage prostate cancer, Hodgkin's lymphoma, and lupus. The last two drugs are the first new drugs approved for treating Hodgkin's lymphoma and lupus in 30 and 50 years, respectively. In addition, two other drugs (for treating melanoma and lung cancer) were approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits.
In a report entitled "FY 2011 Innovative Drug Approvals," the FDA outlined how the agency boosted the number of drug approvals to 35 while maintaining drug safety standards. The report notes that that the FDA achieved faster approval times than its counterparts around the globe. In fact, 24 of the 35 drugs were approved in the U.S. before being approved by any other country. The quick approvals were made possible in part by priority review and accelerated review procedures. FDA Commissioner of Food and Drugs Dr. Margaret Hamburg said that the FDA is "committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century."
Comments